Table of ContentsIndex to Financial StatementsPart IItem 1. These "step down" options provide less symptomatic improvement and are often irritating. All TEAEs were mild to moderate in severity. Data exclusivity for oral roflumilast expired on January 23, 2021. These fees are typically increased annually. Failure to submit required information may result in civil monetary penalties. In many countries, the pricing review period begins after marketing approval is granted. D. From time to time, we also retain independent contractors to support our organization. A failure of one or more clinical trials can occur at any stage of testing. The covered technology and the scope of coverage vary from country to country. We may be required to indemnify future collaborators against such claims. Litigation may be necessary to defend against these claims. In addition, third parties may file first for our trademarks in certain countries. We may not be able to protect our proprietary information and technology adequately. This can be expensive, particularly for a company of our size, and time-consuming. Many foreign regulatory authorities have similar requirements.